跳至主要内容
临床试验/NCT04354818
NCT04354818Unknown不适用

Coronavirus Outcomes Registries in Immunocompromised Individuals Australia (CORIA): a Multisite Registry and Optional Biorepository in People With COVID-19 and Selected Conditions Affecting Immune Function

Kirby Institute11 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年5月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
27
试验地点
11
主要终点
percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died

研究概览

简要总结

CORIA is an observational cohort study of immunosuppressed populations who test positive for COVID-19. This includes people living with HIV, cancer, acquired immunodeficiency associated with other immunosuppressive therapy, primary immunodeficiency and recipients of a solid organ transplant. Participants will have routine clinical data collected with optional baseline collection and storage of a blood sample for storage . The study will be conducted in up to 30 sites within Australia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presenting (in person or via telemedicine) for evaluation because they:
  • Have clinical symptoms consistent with for COVID-19:
  • Fever (≥ 37.8 °C) on examination OR patient reported fever (≥ 37.8 °C) or feverishness (felt febrile but did not take temperature) OR any of, cough, sore throat, shortness of breath, rhinorrhoea, headache, chills, generalise myalgia, malaise, fatigue, confusion, diarrhea, nausea or vomiting
  • Have been contacted because they have been identified as a contact to a confirmed case
  • Have been contacted and told they tested positive for COVID-19
  • Have one of the following conditions affecting immune function:
  • Known or suspected primary immunodeficiency, defined as a predisposition to infection associated with an apparent or presumed deficit of immune function
  • On immunosuppressive therapy
  • Treatment with immune checkpoint inhibitors within 36 months of enrolment date
  • HIV infection
  • Diagnosis of cancer within 36 months of enrolment date, excluding superficial basal cell and squamous cell carcinomas
  • Solid organ transplantation
  • For optional biobanking only, ability to provide informed consent

排除标准

  • 未提供

结局指标

主要结局

percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died

时间窗: Day 28

次要结局

  • percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died(3 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (11)

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